Events

Recall of Device Recall LIFEPAK CR Plus and/or LIFEPAK EXPRESS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Physio-Control, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74198
  • Event Risk Class
    Class 2
  • Event Number
    Z-2100-2016
  • Event Initiated Date
    2016-05-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146712
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Reason
    Lifepak cr plus automated external defibrillators (aed) or lifepak express aed may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.
  • Action
    The firm, Physio Control, sent an "URGENT MEDICAL DEVICE CORRECTION-ACTION REQUIRED"- LifePak CR Plus AE and LifePak Express AED letter and the Confirmation sheet, dated May 2016, to US customers on 5/25/16. Physio will notify international consignees during the week of 6/13/16. The letter described the product, problem and the actions to be taken. The customers were instructed to-URGENTLY bring this letter to the immediate attention of the person(s) responsible for maintaining/monitoring your Automated External Defibrillators (AEDs); follow the instructions on the Confirmation Sheet that outline specific actions to take for the serial numbers listed, and if you have a routine check process, please continue this process. If you have not established a routine check process, please refer to section 5 of the Operating Instructions for recommended actions. In addition, customers should follow the instructions on the Confirmation Sheet and submit this form to Physio by: -Fax to: 1-866-448-9567 -Email to: rsrecall@physio-control.com -Mail to: Physio-Control, Inc. P.O. Box 970006, Dept. 15N Redmond, WA, 98073-9706 Physio-Control will contact customers with LIFEPAK CR Plus and LIFEPAK EXPRESS AEDs that contain the affected reed switch assembly. A device correction including provision of loaner devices and replacement of the reed switch component will be arranged for all affected devices. Customers who have any questions regarding this notification, please call Physio-Control at 1-800-442-1142, 6:00 a.m. to 4:00 p.m. (Pacific), Monday  Friday.

Device

Device Recall LIFEPAK CR Plus and/or LIFEPAK EXPRESS
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and countries of: Argentina, Austria, Australia, Bahamas, Bangladesh, Belgium, Brazil, Brunei Darussalami, Canada, Chile, China, Croatia, Cyprus. Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan (Province of China), Turkey, United Arab Emirates, United Kingdom, New Caledonia, and New Zealand,.
  • Product Description
    LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable. || LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
  • Manufacturer
    Physio-Control, Inc.

Manufacturer

Physio-Control, Inc.
  • Manufacturer Address
    Physio-Control, Inc., 11811 Willows Rd NE, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA